Trial | NCT02494466  Report issue

Title

Preoperative Use of Montelukast Sodium
The Effects on Airway Reactivity of the Use of Preoperative Montelukast Sodium

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    montelukast ...

  • Study Participants

    30
Supraglottic airway equipment used during anaesthesia application can lead to airway reactivity or even larynx spasm in sensitive children.

Montelukast Sodium, used in asthma treatment, is a cysteinyl leukotriene Type 1 antagonist which reduces leukotriene C4, leukotriene D4 and leukotriene E4 synthesis. The use of Montelukast Sodium in airway reactivity is known to reduce the need for bronchodilator and corticosteroids.
The study will comprise 30 american society of anesthesiology (ASA) I-III patients, aged 4-8 years, undergoing inguinal hernia surgery. Patients will exclude if receiving asthma treatment, if they had upper respiratory tract infection in the last week and if the laryngeal mask airway (LMA) could not be placed at a single attempt.

Patients will be separated into 3 groups as Group E (n=10) with high immunoglobulin E (IgE), Group C (n=10) with normal IgE and Group M (n=10) who were administered with 4mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.

With spontaneous breathing after anaesthesia induction, a classic LMA will be placed. Anaesthesia will be maintained with a mixture of 1.3 minimum alveolar concentration (MAC) sevoflurane 500%2 - N2O. At 5-minute intervals, oxygen saturation (sPO2), End-Tidal carbon dioxide, Heart Rate, tidal volume (VT), respiratory rate (f) and peak airway pressure (PAP) will be monitored and coughing, apnea, laryngospasm , bronchospasm, desaturation and need for steroids will be noted.
Study Started
May 31
2014
Primary Completion
Jun 30
2015
Study Completion
Jun 30
2015
Last Update
Jul 10
2015
Estimate

Drug montelukast sodium

4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.

Group E (n=10) Active Comparator

Patients with high Ig E levels

Group C (n=10) Active Comparator

Patients with normal Ig E levels

Group M (n=10) Active Comparator

Patients who would be administered with 4mg PO MS 10 days before surgery because of high IgE

Criteria 

Inclusion Criteria:

Patients undergoing inguinal hernia surgery

Exclusion Criteria:

If receiving asthma treatment,
If they had URTI in the last week and
If LMA could not be placed at a single attempt.
No Results Posted